GondolaBio Service Co, Inc. - Director, Quality Assurance

GondolaBio Service Co, Inc.

Company Background

GondolaBio is a collection of biopharmaceutical companies focused on developing next-generation therapeutics for genetic diseases. Originally carved out of BridgeBio, GondolaBio secured $300M in private financing from external investors in 2024 and became an independent company within the BridgeBio ecosystem. GondolaBio aims to leverage cutting-edge biological research to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases.

Portal Therapeutics is an early clinical stage biotechnology company, and the lead program in GondolaBio’s portfolio. Portal is developing a novel potential best-in-class therapy for erythropoietic protoporphyria, a severe genetic disease of the blood which results in extreme sensitivity to sunlight and liver damage.

To learn more, visit us at gondolabio.com

Who You Are

The Director of Quality Assurance (QA) will lead the development and execution of quality strategies supporting clinical-stage and/or commercial products. This role ensures compliance with global GxP regulations while operating in a fast-paced, innovation-driven setting. The Director will continue to build scalable quality systems, support regulatory submissions, and provide QA oversight across clinical development, manufacturing, and external partnerships.

1. Quality Systems & Build-Out

• Continue to build, implement, and scale a phase-appropriate Quality Management System (QMS)
• Establish SOPs, quality policies, and training frameworks for a growing organization.
• Ensure inspection readiness at all times.

2. Clinical & Development QA

• Provide QA oversight for GCP and GLP activities supporting clinical trials
• Review clinical protocols, investigator brochures, and study reports
• Support IND, BLA, or MAA submissions with quality input

3. CMC & Manufacturing Oversight (Initial Focus of Role)

• Oversee GMP compliance for products in development.
• Provide QA support for tech transfer, process development, and scale-up.
• Ensure proper review and disposition of batch records, deviations, and investigations.

4. External Partner & Vendor Quality

• Manage QA oversight of CDMOs, CROs, and suppliers across all functions.
• Lead vendor qualification, audits, and quality agreements
• Monitor partner performance and compliance

5. Regulatory Inspections & Audits

• Ensure readiness and hosting of FDA, EMA, and global regulatory inspections
• Manage internal audits and mock inspections
• Drive CAPA development and effectiveness checks

6. Risk-Based Quality & Innovation

• Apply ICH Q9 risk management principles in decision-making
• Implement agile, scalable QA processes suited for company’s growth stages
• Leverage digital tools and data analytics for quality insights

7. Leadership & Culture

• Work and partner with a high-performing QA team
• Promote a “quality by design” mindset across the organization
• Partner cross-functionally with R&D, Clinical, Regulatory, and Technical Operations

Education, Experience, & Skills Requirements

Education

• Bachelor’s degree in Life Sciences (Biology, Biochemistry, Molecular Biology, etc.)
• Advanced degree (MS, PhD) preferred

Experience

• 10–15 years in QA within biotech or biopharma
• Strong experience in clinical-stage development and manufacturing
• Proven leadership in a startup or high-growth biotech environment preferred

Core Competencies

• Expertise in GMP, GCP, GLP regulations and compliance
• Strong experience with regulatory submissions (IND, BLA, MAA)
• Ability to build systems from the ground up and scale with growth
• Excellent leadership, communication, and cross-functional collaboration

Preferred Skills

• Familiarity with digital QMS tools (e.g., Veeva)
• Experience preparing for pre-approval inspections (PAI)

What We Offer

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts.
• A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak.
• An unyielding commitment to always putting patients first.
• A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science.
• A place where you own the vision – both for your program and your own career path.
• A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game.
• Access to learning and development resources to help you get in the best professional shape of your life.
• Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs).
• Flexible PTO
• Rapid career advancement for strong performers.
• Partnerships with leading institutions.
• Commitment to Diversity, Equity & Inclusion.

The base pay range for this position is $220,000 to $250,000 per year. The actual compensation offered will be determined based on a number of job-related factors, including experience, skills, qualifications, and location. A bonus plan and equity will also be offered.